GENE-ENVIRONMENT INTERACTIONS INFLUENCING ALCOHOL-RELATED PHENOTYPES AND DISEASES RELEASE DATE: June 19, 2003 PA NUMBER: PA-03-141 March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Parent R03 (PA-06-180) and R21 (PA-06-181) funding opportunity announcements have been issued for the submission date of June 1, 2006 and submission dates thereafter. Applications relating to R33 and R34 activities must be in response to NIH Institute/Center (IC)-specific announcements. EXPIRATION DATE: May 1, 2006 National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov) National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: 93.273, 93.113, 93.114, 93.115 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute on Alcohol Abuse and Alcoholism is seeking research grant applications on the role of gene-environment interactions underlying susceptibility to alcohol-related phenotypes including alcohol dependence, relapse, withdrawal; alcohol-induced organ damage including neurodegeneration, cirrhosis and other liver diseases, pancreatitis, cardiomyopathy, immune disorders, cancers, and alcohol-induced birth defects. This solicitation specifically encourages multidisciplinary approaches to study how environmental conditions, such as chemical, infectious, physical, nutritional, and social behavioral factors, impact genetic predisposition to alcohol-related diseases. Identification and characterization of gene- environment interactions will offer better opportunities to effectively target prevention, intervention and treatment strategies. The National Institute of Environmental Health Sciences is collaborating on this PA and is seeking research grant applications on interactions between alcohol effects and environmental agents. RESEARCH OBJECTIVES BACKGROUND Alcoholism and alcohol-related diseases are the result of complex interactions of multiple genetic and environmental factors. Several genetic factors have been associated with alcohol-related behaviors, alcohol-induced birth defects, and alcohol-induced organ damage; however, the role of environmental factors in modifying the risk of developing alcohol abuse, alcoholism, and/or organ damage remains undefined. Genetic factors leading to differential risk for alcoholism were demonstrated using twin and family studies. In addition, functional polymorphisms of alcohol dehydrogenase(ADH2) and aldehyde dehydrogenase (ALDH2) genes have been shown to have a significant impact on alcohol metabolism in the liver, and thus, may contribute to vulnerability to alcohol abuse and dependence, alcohol-related liver diseases and cancers. Genetic and environmental interactions modulate an individual's susceptibility to certain diseases/disorders. For example, male children who have a polymorphism in the monoamine oxidase A gene conferring low enzyme activity show non aggressive behavior when raised in a non-abusive environment. However, male children with the same polymorphism show aggressive and antisocial behavior when raised in an abusive environment. Males with normal enzyme activity do not become violent offenders when raised in the same abusive/maltreated environment. Similar results have been found in animals. For example, mice lacking a functional corticotroping-releasing hormone 1 receptor do not differ from wild-type mice in alcohol intake under stress-free conditions; however, after repeated stress, the knockout mice increase their alcohol consumption. Also, monkeys with a polymorphism in the regulatory region of the serotonin transporter gene show no differences from the wild-type monkeys when reared with their mothers. However, monkeys with the polymorphism that were nursery raised have attention and orientation deficits. The dynamic multi-level interactions between genetic and environmental components are responsible for the heterogeneity and complexity of alcohol dependence phenotypes. Therefore, it is necessary to use multi-disciplinary approaches to decipher the underlying mechanisms for alcohol abuse, alcohol dependence and alcohol related disorders. Comprehensive designs and methodologies for both human and animal studies of gene-environment interactions are of crucial importance to identify alcohol-related genes and environmental factors, and their interrelationships. Human studies using informative populations such as twins, multi-generation families and migrants, as well as children at high risk or low risk to develop alcohol dependence can provide unique opportunities and advantages to study neurobiological and behavioral consequences of gene-environment interaction. In addition, animal models can be used to study gene-environment interactions requiring genetic and environmental manipulations that are impractical or ethically impossible in humans. Controlled genotypes can be devised in genetically modified or chemical-induced mutant animals. Therefore, animal models can also offer unique opportunities to explore the role of gene- environment interactions as the means of understanding the pathways to alcohol-induced diseases. There are several approaches for analyzing the effects of environmental factors in experimental animals, including differential gene expression using cDNA microarrays, RAGE, and SAGE; as well as proteomic methods to determine changes in protein levels and protein modifications. The role of genes implicated in the response may be further studied by developing transgenic and gene-targeted animals, as well as, by using other gene expression strategies including RNA interference (RNAi) and retroviral-mediated gene transfer techniques. Epigenetic changes are known to be involved in the etiology of a large number of diseases such as schizophrenia, cancer, and alcohol dependence. Recent evidence shows that there is an association between the GABAA receptors and alcohol dependence that is modulated by genetic imprinting. There are numerous types of epigenetic modifications on both DNA and nucleosomes, including methylation and acetylation, which could affect the expression and regulation of alcohol-related genes. NIAAA seeks proposals that will examine environmental factors that alter the epigenetic status of genes that may affect gene expression leading to alcohol-induced diseases. RESARCH SCOPE The purpose of this PA is to encourage multidisciplinary research that will investigate gene-environment interactions influencing susceptibility to alcohol abuse and dependence, alcohol-related behaviors, and alcohol-induced organ damage in both animals and humans. NIAAA seeks research projects that include, but are not limited to: o studies of changes in gene or protein expression by investigating animal models such as knock-out and other genetically modified animals under a variety of environmental conditions to identify candidate genes, or their corresponding proteins, that may be associated with susceptibility to alcohol abuse and dependence, relapse, withdrawal, alcohol-induced organ damage including neurodegeneration, cirrhosis and other liver diseases, pancreatitis, cardiomyopathy, immune disorders, cancers, and alcohol-induced birth defects; o studies to identify allelic variants (polymorphisms) and determine the functional relevance of an identified gene or protein for increasing or decreasing susceptibility to alcohol abuse and dependence, alcohol-related phenotypes, and other alcohol-induced diseases under different environmental conditions; o studies using genetic epidemiological, psychiatric and behavioral genetic and molecular genetic methods to determine the interaction of genetic, biological, and social factors in the development of risk to alcohol abuse and dependence; o studies to develop and/or utilize statistical modeling approaches to identify the contributions of genetic and environmental factors to the individual risk, their interrelationship and their developmental trajectories; o studies to determine the genetic and environmental risk and protective factors that influence individual drinking behaviors including children and adolescent underage drinking across populations, socio-cultural backgrounds, and environmental exposures; o studies to determine the environmental factors that alter the epigenetic status of genes, thus increasing vulnerability to alcohol abuse and dependence, alcohol-associated behaviors, and alcohol-induced organ damage; o studies to determine the functional relevance of candidate genomic markers associated with an increased susceptibility to alcohol abuse and dependence, alcohol-related phenotypes, and alcohol-associated medical conditions; o studies to identify potential links between alcohol exposure and expression of functional polymorphisms of neurotransmitters and their receptors under various environmental conditions such as stress and cross-fostering, to understand the development of excessive drinking behaviors. o studies to determine how genetic variations between individuals and among various populations impact on how environmental influences may differentially alter alcohol metabolism. NIEHS seeks research grant applications in which the goals are to determine gene-environment effects on disease susceptibility in response to specific exposures or which involve Environmentally Responsive Genes, for example, as defined in the Environmental Genome Project (http://egp.gs.washington.edu/). NIEHS seeks applications that focus primarily on exposure to environmental agents and in which attention to alcohol abuse is secondary or minor. MECHANISM(S) OF SUPPORT This PA will use the NIH R01 and Exploratory/Developmental Research Grant (R21) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Applications using the R21 mechanism may request a project period of up to two years with a combined budget for direct costs of up $275,000 for the two year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non- modular research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. Exploratory/developmental grant support is for new projects only; competing continuation applications will not be accepted. Two revisions of a previously reviewed exploratory/developmental grant application may be submitted as defined in NIH Policy at http://grants.nih.gov/grants/policy/amendedapps.htm. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct questions regarding human genetics and genetic variations to: Zhaoxia Ren, M.D., Ph.D. Program Director, Genetics and Proteomics Research Branch Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-5733 Fax: (301) 594-0673 Email: zren@mail.nih.gov o Direct questions about genetic animal models and proteomics to: Lisa A. Neuhold, Ph.D. Program Director, Genetics and Proteomics Research Branch Division of Basic Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 594-6228 Fax: (301) 594-0673 Email: Lneuhold@willco.niaaa.nih.gov o Direct questions about neuroscience and behavioral studies to: Ellen Witt, Ph. D. Program Director, Neuroscience and Behavior Research Branch Division of Basic Research National Institute on Alcohol Abuse and Alcoholism Willco Bldg, Suite 402 6000 Executive Blvd, MSC 7003 Bethesda, MD 20892-7003 Tel: (301) 443-6545 Fax: (301) 594-0673 Email: ewitt@willco.niaaa.nih.gov o Direct questions regarding epidemiological and statistical studies to: Vivian B. Faden, Ph.D. Chief, Epidemiology Branch Division of Biometry and Epidemiology National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 592-6232 Fax: (301) 443-8614 Email: vfaden@mail.nih.gov o Direct questions regarding interactions between alcohol and environmental agents to: Leslie Reinlib, PhD Scientific Program Administrator Susceptibility and Population Health Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences PO Box 12233, MD-EC-21 Research Triangle Park, NC 27711 Telephone: (919) 541-4998 Fax: (919) 316-4606 Email: reinlib@niehs.nih.gov o Direct inquiries regarding fiscal matters to: Judy Fox (formerly Simons) Chief, Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 504 Bethesda, MD 20892-7003 Telephone: (301) 443-4704 Fax: (301) 443-3891 Email: jsimons@willco.niaaa.nih.gov OR Carolyn Winters Grants Managment Specialist Grants Management Branch Division of Extramural Research and Training National Institute of Environmental Health Sciences PO Box 12233, MD-EC-22 Research Triangle Park, NC 27711 Telephone: (919) 541-7823 Fax: (919) 541-2860 Email: winters@niehs.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must contact the proper program official identified above to receive authorization to submit the proposal. The applicant must include a cover letter identifying the NIAAA program official who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score. o Receive a second level review by an appropriate national advisory council or board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The sharing of biological materials, interview and other assessment data, and genotype information (including software) in a timely manner has been an essential element in the rapid progress that has been made in the genetic analysis of human diseases. PHS policy is that investigators must make unique research resources readily available for research purposes to qualified individuals within the scientific community when first results based on these resources have been published (PRINCIPLES AND GUIDELINES FOR RECIPIENTS OF NIH RESEARCH GRANTS AND CONTRACTS ON OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES; published on December 23, 1999 in the Federal Register) http://www.ott.nih.gov/policy/rt_guide_final.html. Accordingly, to address the interests of the research community and government in promoting the science of the genetic basis of alcohol abuse and alcoholism vulnerability, NIAAA expects applicants who respond to this PA to develop and propose detailed plans for sharing the data and materials generated through the grant. It is expected that the Data Sharing Plan will specify the following elements: 1) creation of comprehensive and verified databases that contain all clinical, diagnostic, pedigree structure, and genotypic information collected and produced by the grant, 2) establishment of cell lines (from which DNA will be extracted and stored) from all protocol subjects from whom blood samples have been obtained, 3) a mechanism or protocol by which all databases and biological materials (DNA samples, cell lines) can be widely searched or distributed to qualified investigators in the scientific community, 4) a timetable specifying when various elements of the database (e.g., diagnostic, assessment, or genetic data) will be available for distribution. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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